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Posted: 06-Dec-24
Location: Tucson, Arizona
Type: Full Time
Years of Experience:
Salary Details:
Required Education:
As a Laboratory Director, you have clinical oversight of Precision Epigenomics’ laboratory testing. You ensure that testing is properly performed, and applicable regulatory standards are met. You are accountable for ensuring that laboratory processes consistently provide accurate and reliable patient test results.
PRIMARY RESPONSIBILITIES:
- Review and approve test reports for DNA methylation results on our qRT-PCR platform, and other methodologies.
- Oversee the review and interpretation of DNA methylation data: interpret results detected by multiple technologies (e.g., qRT-PCR, etc.) in the context of medical literature, online epigenomic databases, and other references along with relevant patient demographic data.
- Provide clinical and technical support for healthcare providers and other laboratory personnel.
- Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.
- Analyze lab data, contribute to, or write publications for high-quality scientific journals.
May serve as Clinical Consultant. A Clinical Consultant is responsible for ensuring:
- Test reports include pertinent information for test interpretation, and
- Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions.
May serve as Technical Supervisor. A Technical Supervisor is responsible for ensuring:
- Appropriate test method selection
- Adequate method validation to determine the accuracy and precision of the test
- Enrollment and active participation of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed in accordance with the CLIA requirements and:
- PT results are returned within established time limits PT reports are reviewed by the appropriate staff
- If applicable, corrective action plans are developed and executed for any unacceptable or unsatisfactory PT results.
- Quality assessment and quality control programs are established and maintained
- Acceptable analytical test performance is established and maintained for each test system
- Remedial actions are taken and documented when significant deviations from the laboratory's established performance characteristics are identified, and patient test results are reported only when the system is functioning properly
- Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens
- Policies and procedures are established for monitoring personnel competency in all phases (preanalytical, analytical, and postanalytical) of testing to assure the ongoing competency of all individuals who perform testing.
- Remedial training or continuing education needs are identified, and training provided; and an approved procedure manual is available to all personnel.
May manage a team:
- Review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management.
- Work collaboratively with other departments
PHYSICAL DEMANDS & WORK ENVIRONMENT:
- Duties typically performed in BSL-2 lab setting.
- Standing or sitting for long periods of time may be necessary.
- Duties may require working various shifts, weekends, and/or overtime.
Travel required for this position:
Yes: up to 10%
OUR OPPORTUNITY
Precision Epigenomics™ is a leader in cell-free DNA (cfDNA) testing, dedicated to oncology. Our aim is to make personalized epigenetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Precision Epigenomics team consists of highly resolute doctors, laboratory scientists, and business professionals who care deeply for our work and each other. When you join Precision Epigenomics, you will work hard and grow quickly. Collaborating with the elite of the industry, you will be stretched, challenged, and will take pride in being part of a company that is changing the landscape of early cancer detection.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical plans for eligible employees and their dependents.
For more information, visit www.Precision-Epigenomics.com.
Precision Epigenomics is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of diverse backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability, or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.Precision-Epigenomics.com/notice-of-data-collection-california-residents/
Please be advised that Precision Epigenomics will reach out to candidates with an @Precision-Epigenomics.com email domain ONLY. Email communications from all other domain names are not from Precision Epigenomics or its employees and are fraudulent. Precision Epigenomics does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Precision Epigenomics takes cybercrimes seriously and will collaborate with law enforcement authorities to prosecute any related cybercrimes.
QUALIFICATIONS:
- MD/DO and/or PhD in genetics or related field required.
- ABMGG board-certified in Molecular Genetics or Laboratory Genetics and Genomics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.
- Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Laboratory Geneticist required.
- Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.
- Both the California Clinical Laboratory Geneticist and the ABMGG Clinical Laboratory Genetics and Genomics certification are preferred.
- 2 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting, and reporting clinical epigenetic/genomic data. Experience within a high-volume laboratory is preferred.
- 2 or more years of experience in development and implementation of molecular test interpretation processes and systems in line with published professional interpretation guidelines. Additional variant interpretation experience and involvement in professional committees and/or organizations is preferred.
- Knowledge of CAP, CLIA, California, and New York state regulations.
- Management experience required.
- This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) to perform the job.
- Employees must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Must maintain current status on Precision Epigenomics training requirements.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Excellent written and oral communication skills.
- Experience leading and managing teams within a high-complexity laboratory environment that offers screening, constitutional, and somatic clinical testing.
- Strong background in evaluating, interpreting, and reporting of advanced, high complexity molecular technologies used to detect DNA methylation variation including qRT-PCR and next-generation sequencing.
- Understanding of bioinformatics & statistical measures utilized in epigenomic testing.